Patients with heart failure, iron deficiency and anaemia with either reduced or preserved left ventricular ejection fraction MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: LLT Classification code 10024106 Term: Left heart failure System Organ Class: 100000004849 MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved
Conditions
Interventions
Trade Name: FERACCRU®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ferric maltol
CAS Number: 33725-54-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men, women*, inter/diverse aged = 18 at day of inclusion 2. Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures 3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial 4. Patients with chronic heart failure with an LVEF50 m 6. Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin concentration =8 g/dl and 1 year or • 1 year with serum FSH > 40 IU/l and serum estrogen =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Active haematological disorders other than anaemia and/or iron -deficiency 2. Other medical condition that according to the investigator’s assessment is causing or contributing to anaemia 3. Active malignancy or currently receiving chemotherapy or radiotherapy 4. Active infectious disease 5. Active bleeding 6. Severe renal insufficiency (GFR 3 x upper limit of normal or bilirubin levels >50 µmol/l 8. Ongoing oral or intravenous iron supplementation 9. Concomitant erythropoietin medication 10. Concomitant therapy with Dimercaprol, Chloramphenicol and Methyldopa 11. ESA, i.v. iron or blood transfusion administered in last 3 months and oral iron (>100 mg/day) in previous 4 weeks 12. Pregnancy or lactation period 13. Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study 14. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product 15. Known haemochromatosis or other iron overload syndromes 16. Patients with severe, uncorrected valvular heart disease 17. Clinical evidence of ACS, TIA or stroke within the last 30 days 18. CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery leading to significant blood loss within last 30 days 19. Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery 20. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with Vitamin B12 or folic acid deficiency who in the opinion of the Investigator are stable and asymptomatic will be permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: - To assess the effects of oral ferric maltol on change in haemoglobin levels from baseline to week 16 in heart failure patients with iron deficiency and anaemia;Secondary Objective: Secondary objective: - To assess the effects of oral ferric maltol on serum ferritin, transferrin saturation, soluble transferrin receptor 1, 6 min walking distance, HRQoL (measured by KCCQ-12), serum NT-proBNP, left and right ventricular function (determined by echocardiography), liver and renal function and NYHA class in heart failure patients with iron deficiency and anaemia Assessment of safety: - To assess the safety and tolerability of oral ferric maltol in heart failure patients with iron deficiency and anaemia;Primary end point(s): Primary endpoint(s): Change in haemoglobin level from baseline to week 16;Timepoint(s) of evaluation of this end point: from baseline to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: (1) from baseline to week 16 (2) from baseline to week 16 (3) from baseline to week 16 (4) from baseline to week 16 (5) from baseline to week 16 (6) from baseline to week 16 (7) from baseline to week 16 (8) from baseline to week 16 (9) from baseline to week 16 (10) from start of treatment until FU (11) from start of treatment until FU ;Secondary end point(s): Secondary endpoint(s): (1) Change in serum ferritin and transferrin saturation from baseline to week 16 (2) Change in soluble transferrin receptor 1 from baseline to week 16 (3) Change in 6 min walking distance from baseline to week 16 (4) Change in HRQoL (measured by KCCQ-12) from baseline to week 16 (5) Change in serum NT-proBNP from baseline to week 16 (6) Change in echocardiographic markers of left ventricular function (left ventricular ejection fraction, left ventricular diameter, left ventricular end-systolic volume index, left ventricular end-diastolic volume index, left ventricular wall thickness, left atrial volume index, global longitudinal strain, markers of diastolic function (E/e’, E/A, deceleration time, IVRT) and right ventricular function (right ventricular diameter, tricuspid annular plane systolic excursion, estimated systolic pulmonary arterial pressure) from baseline to week 16 (7) Liver: Change in Albumin, ALT, AST and Bilirubin from baseline to week 16 (8) Kidney: Change in Creatinine (+GFR) and Urea from baseline to week 16 (9) Change in NYHA class from baseline to week 16 Assessment of safety: (10) Treatment-emergent adverse events (AEs) (11) number of drop-outs due to AEs | — |
Countries
Germany
Contacts
Public ContactDepart.of Cardiology and Angiology
Hannover Medical School,
Outcome results
None listed